1. REACH
CLOSER
to
the
Truth
EmpiriStat, Inc.
2011 Corporate Capabilities Summary
BIOSTATISTICAL
SYNERGY
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[1]

2. EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[2]

3. Corporate Capabilities
Summary
REACH CLOSER to the Truth
Quick Facts About
EmpiriStat,
Inc.
Woman-Owned Small EmpiriStat
was
founded
with
a
unique
goal:
to
discover
the
truth
as
far
as
Business possible.
As
biostatisticians
and
clinical
trialists,
we
believe
reaching
this
goal
is
only
possible
by
going
beyond
analytics.
For
every
research
and
development
Federalwide Assurance
(FWA) A00015488 project,
science
and
fact
extend
along
a
timeline
in
both
directions—past,
present
and
future.
Applying
rigorous
methodologies
and
experience
at
every
CAGE Code: 53F97
point
along
this
timeline
results
in
outcomes
that
are
as
close
to
the
truth
as
DUNS Number: 826391034 possible.
Small Business NAICS codes:
518210 541519 541611 Our
work
lies
at
the
intersection
of
science
and
practice.
We
bring
in
depth
541690 541712 541720 experience
to
your
research
and
development,
along
with
accurate
541990 611420 611430 documentation,
rigorous
quality
control,
and
regulatory
compliance.
We
work
efficiently
under
tight
project
deadlines
without
compromising
quality.
EmpiriStat, Inc. Professional
Development and Training We
work
with
clients
interested
in
ongoing
communication
and
dialogue
Education and training is the between
disciplines
and
our
experience
comes
from
collaborating
with
many
cornerstone of EmpiriStat. researchers
over
a
wide
range
and
complexity
of
studies
in
epidemiology
and
Without the tools for continuous various
medical
and
device
specialties.
We
are
committed
to
providing
and
improvement professionally and maintaining
the
highest
scientific
rigor
and
ethical
standards—while
providing
personally, we believe we lose both
timely
and
cost-­‐effective
services.
the insight, knowledge, and
passion to further ourselves,
our career, and our business. Commitment
to
Excellence
Training is the process of We
at
EmpiriStat
are
committed
to
“We have the passion for
developing specific skills to building
long
lasting
collaborative
making things happen with an
perform a certain job or task relationships
with
our
clients.
We
more efficiently, and education urgent patience, optimism, and
believe
that
to
forge
these
effective
is noted to be the overall relationships,
we
must
remain
true
to
a tolerance for uncertainty. It is
development of the human our
key
values:
responsibility,
integrity,
not just the respect for our
mind. EmpiriStat offers a wide
value,
and
commitment
to
excellence
in
knowledge in the field that we
range of specific training
sessions, such as Good Clinical
every
role
and
task
we
undertake.
possess, but taking action and
Practice (GCP) training, Site
doing valuable work with that
Management Training, or Data Our
underlying
foundation
at
EmpiriStat
is
a
belief
that
we
can
make
a
knowledge.”
and Safety Monitoring Board
(DSMB) Training. We also offer difference
in
the
world
and
we
will
try
a wide variety of Professional to
do
that
each
and
every
day.
We
have
~ Dr. Nicole Close, President
Development courses, such as the
passion
for
making
things
happen,
Educational Modules in coupled
with
a
genuine
reserve
of
good
will,
from
professionals
who
are
Biostatistics for Non-
excited
to
share
and
contribute
their
knowledge
and
experience,
but
who
are
Statisticians, Epidemiology,
equally
compelled
to
learn
and
to
engage
themselves
in
that
process
to
Data Management, and
Pharmacovigilance. Please continually
improve
corporately,
professionally
and
personally.
contact us to request a
Professional Development and
Training Brochure.
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[3]

4. SELECTED CASE STUDIES Services
Challenge: A pharmaceutical We
offer
the
following
major
clinical
research
collaboration
and
services:
company was only months away Biostatistics
Statistical
Programming
from filing their NDA with the Data
and
Safety
Monitoring
Board
Services
FDA. They did not have an in-
Project
Management
house Biostatistics/Statistical
Programming group for review
Statistical
Software
and
Programming
Validation
and writing of the ISS SAP and Clinical
Data
Management
to conduct the validation Clinical
Site
Management
programming for their program. Clinical
Monitoring
Services
Safety
Monitoring
and
Reporting
Services
Statistical Analysis: EmpiriStat
collaborated with the company Regulatory
Support
Services
and provided all of the services Scientific
Administrative
Support
required as the Sponsor’s in- Biostatistical
Synergy
house Biostatistics and Statistical
Programming group to support
both the ISS and the NDA filing
within a very condensed
Biostatistics
and
Statistical
Programming
timeframe without compromising EmpiriStat
provides
a
wide
range
of
services
throughout
every
project
and
quality. clinical
trial
phase.
Some
services
–
such
as
statistical
programming
of
tables,
listings,
and
figure
shells
–
provide
cost
and
time
savings
to
our
collaborator
if
Result: The company received
the Biostatistical guidance,
programmed
and
validated
while
the
trial
is
writing, review and statistical ongoing
(instead
of
during
the
database
closure
and
validation programming from analysis
phase).
The
range
of
our
assistance
can
be
EmpiriStat to complete the filing categorized
loosely
by
project/trial
phase
within the existing company (Implementation,
Ongoing,
Database
Closure,
timelines. The company saved Analysis,
Post
Clinical
Trial,
and
General)
and
range
time and money by consulting from
hypothesis,
objectives
and
endpoint
planning,
Protocol
and
Statistical
with EmpiriStat who provided Analysis
Plan
writing/review,
Sample
size/power
calculations,
Statistical
flexible, time efficient and cost programming
specifications,
to
Interim
data
monitoring/analysis,
Database
effective services in an expedited
review
and
cleaning,
and
Primary
statistical
analysis
and
secondary
review
of
manner set by the client’s needs.
statistical
analysis
and
interpretation.
Challenge: The client had
contracted with EmpiriStat for
Data
and
Safety
Monitoring
Board
Services
part-time Senior Clinical and Establishing,
managing,
and
participating
on
a
Data
and
Safety
Monitoring
Regulatory Affairs Management Board
(DSMB)
is
a
serious
process.
EmpiriStat
has
the
skills,
knowledge,
and
and expertise. The client was experience
to
perform
DSMB
services
professionally
and
effectively.
As
a
also in the process of contracting partner
in
the
process,
we
assist
the
Sponsor
in
DSMB
member
identification
for a full service CRO to provide and
selection,
DSMB
training,
and
full
administrative
support
services.
Our
Data Management, Clinical professional
management
and
secure
data
analysis
and
delivery
ensures
Monitoring, Safety Reporting, leadership
to
assist
with
establishing
the
objectives,
responsibilities,
and
Biostatistics, and Regulatory
procedures
through
an
official
charter.
We
also
have
the
expertise
to
establish
support for their multi-center
clinical trial. However, the client
procedures
for
the
review
of
safety
data,
and
we
are
fully
qualified
to
act
as
was having contracting the
unblinded
partner
in
performing
the
statistical
analysis
and
facilitation
of
difficulties and the trial timelines the
exchange
of
information
between
the
DSMB
members,
DSMB
Chair,
and
were being delayed. Sponsor.
Solution: EmpiriStat was
contracted by the client to
expand their current services to
provide a Bridge until the CRO
could be selected and
contracted. In a condensed
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[4]

5. timeline of just 4 months,
EmpiriStat created the
Project
Management
deliverables and provided the EmpiriStat
has
the
experience
and
capability
to
succeed
at
collaborating
and
on-site professionals to initiate managing
overall
projects
and
clinical
trials
beyond
statistical
services.
We
the clinical trial (including have
the
ability
to
provide
critical
leadership
across
the
entire
project
team,
complete Case Report Forms, and
we
work
with
the
sponsor
to
complete
deliverables
and
strive
to
meet
Manual of Procedures, a Safety project
timelines
and
budget
specifications.
Our
Project
Management
support
Reporting System, Study Specific will
guide
your
study
with
seamless
communication
that
will
define
and
Procedures, Establishment and complete
your
project
on
time,
and
on
budget.
Some
of
our
PM
services
can
procedures for a Data and Safety include
“hands-­‐on”
oversight
from
concept
to
completion,
coordination
and
Monitoring Board, all training
review
of
project
deliverables
such
as
Protocols,
CRFs,
and
other
clinical
study
modules, Clinical Monitoring Plan
and 2 certified research
tools,
and
study
budget
forecasting
and
contract
negotiation.
We
also
develop
coordinators and one Risk
Analysis
Plans,
Outsourcing
Plans,
and
Contingency
Plans
to
reach
your
professional consultant). A clear project
milestones.
transition plan was developed
between EmpiriStat’s Bridge of
Statistical
Software
and
Programming
Validation
services to the CRO.
Validation
is
a
critical
element
in
clinical
trials,
and
EmpiriStat
provides
Result: The client moved valuable
insight
for
the
entire
validation
process,
including
assistance
with
forward with the deliverables validation
procedures
and
documentation
of
statistical
software
installation,
required to initiate the trial
operation
and
performance
qualification,
SAS®
Macro
and
statistical
without further delay, had no
programming
validation,
and
independent
review
and
assessment
of
corporate
cost or delay associated with a
new group getting up to speed statistical
software
validation
procedures,
processes
and
documentation.
on the trial since EmpiriStat was
currently providing management Clinical
Data
Management
guidance. It saved time and
Effective
and
well-­‐executed
data
management
is
a
vital
part
of
any
project
or
money when the CRO was hired
since all primary deliverables had
clinical
trial,
and
EmpiriStat’s
Data
Management
services
been created for the study. ensure
the
quality
of
your
results.
EmpiriStat
is
capable
of
providing
full
data
management
services
to
include
the
design
and
review
of
case
report
forms,
Data
Challenge: A European device Management
Plans,
and
the
development
of
edit
company was preparing for filing specifications.
We
also
have
the
ability
to
develop
and
with the US FDA with a device implement
a
clinical
database
to
collect
and
store
study
data,
and
perform
already approved in Europe. medical
coding
using
MedDRA
and
WHO
Drug
dictionaries.
EmpiriStat
is
proud
They had consulted with an
to
be
capable
of
supporting
studies
that
are
paper-­‐based,
electronic,
or
a
academic Biostatistician in the
hybrid
of
both.
US, but were unsure of the
analyses and recommendations
that the Biostatistician had made Clinical
Site
Management
and was looking for an Selection,
evaluation
and
qualification
of
clinical
sites
and
investigators
are
independent senior statistical
critical
for
the
successful
execution
and
completion
of
clinical
trials.
The
site
opinion.
selection
process
and
the
relationship
of
the
sponsor-­‐site-­‐investigator
are
key
Solution: EmpiriStat was areas
of
opportunity
in
accelerating
the
drug
and
device
development
process
consulted to review the while
generating
high
quality
data.
Site
selection
is
a
crucial
decision
that
statistical analyses and needs
to
be
made
by
the
Sponsor
in
which
both
obvious
and
underlying
recommendations and to provide
challenges
are
addressed
and
efficiencies
are
made.
Considerations
we
take
their own assessment prior to
the company filing. EmpiriStat
into
account
are
the
potential
of
patient
recruitment
and
retention;
the
statisticians (PhD Biostatistician experience
of
the
site
Principal
Investigator,
quicker
start-­‐up
processes,
the
with US Regulatory experience increased
competition
among
Sponsors
for
sites,
patients,
increased
and an EmpiriStat UK Statistical globalization
of
trials
and
key
players,
and
FDA
and
international
regulations.
Consultants versed in EMEA EmpiriStat
assists
the
Sponsor
in
creating
site
selection
and
management
guidances) reviewed the processes
by
taking
an
in-­‐depth
look
at
specific
steps
and/or
a
critical
analysis
information and provided a of
existing
practices,
challenges
and
provide
an
opportunity
to
formulate
a
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[5]

6. detailed Statistical Risk Analysis more
solid
partnership
between
Sponsors,
sites
and
investigators.
of the filing.
Result: The device company Our
team
has
successfully
implemented
clinical
trial
sites,
and
we
have
proven
was provided with a detailed processes
for
starting
new
sites
that
remain
lasting
ones
through
in-­‐depth
Statistical Risk Analysis training,
education
and
continual
mentoring.
summary and an independent
assessment. The company made
modifications to their filing based
Clinical
Monitoring
Services
upon EmpiriStat’s Frontline
attention
to
detail
and
quality
comes
from
well-­‐developed
clinical
recommendations and monitoring
plans
and
their
appropriate
execution.
EmpiriStat
embraces
the
successfully filed with the US philosophy
that
the
biostatistician
and
data
manager
works
with
the
clinical
FDA. monitor
in
those
plans
in
order
to
provide
insight
into
key
variables
and
issues
of
data
collection
and
recording
that
may
have
an
impact
on
the
final
analyses.
Early
identification
prevents
issues
later
and
saves
staff
time
and
costs.
We
Therapeutic Experience
assist
our
collaborators
with
expertise
in
quality
assurance
of
study
operations,
• Infectious Diseases
writing
and
implementing
clinical
monitoring
plans,
monitoring
reports,
as
well
• Vaccines as
protocol
and
regulatory
compliance
review.
• Traumatic Brain Injury It’s
our
standard
to
have
a
very
short
turnaround
time
for
issuing
our
reports.
• Transplants and Immunology
Something
we
take
great
pride
in
and
have
been
commended
on
by
many
of
• Anti-Infectives
• Reproductive Health
our
clients.
• Medical Devices
• Dermatology Safety
Monitoring
and
Reporting
Services
• Blood Products
EmpiriStat
offers
a
comprehensive
plan
to
help
you
manage
your
pre-­‐
and
• Wound Care
• Oncology
post-­‐marketed
product
safety
program.
This
management
and
services
may
• Diabetes include
Serious
Adverse
Event
(SAE)
and
Adverse
Event
(AE)
reporting,
SAE
and
• Cardiovascular Disease AE
MedDRA
coding,
examining
current
treatment
utilization
patterns,
SAE
narrative
writing,
submission
to
regulatory
authorities,
generation
of
MedWatch
(3500A/CIOMS)
Forms,
preparation
of
periodic
safety
update
reports
(PSURs)
and
periodic
adverse
drug
experience
reports
(PADERs.
We
Global Depth and Diversity
follow
the
FDA's
Good
Pharmacovigiliance
Practices
and
EMEA's
European
• Government Directive
2001/20/EC
guidelines
and
focus
our
work-­‐products
on
the
end-­‐user
• Non Profit Organizations perspective.
• Private Industry For
those
studies
that
require
use
of
an
Independent
Safety
Monitor,
our
• Academic
EmpiriStat
Consultants
stand
ready
to
perform
those
functions
as
well,
safely
partitioned
and
fire-­‐walled
from
our
Safety
Department
and
project
staff.
• Private Practices
Regulatory
Support
Services
“Empiristat
runs
a
client-­‐focused
business
EmpiriStat
offers
tailor
made
regulatory
services
to
assists
Sponsors
and
with
customer
satisfaction
and
quality
of
services
as
their
top
priorities.
They
serve
as
Investigators
with
the
administrative
activities
involved
in
meeting
the
the
protocol
statisticians
for
my
research
regulatory
requirements
for
research
involving
human
subjects.
We
can
studies,
participate
in
data
safety
assure
that
study
projects
and
protocols
comply
with
federal,
state,
and
monitoring
boards,
and
even
developed
a
institutional
requirements
governing
the
conduct
and
implementation
of
each
statistical
capacity-­‐building
workshop
for
trial,
and
can
serve
as
a
liaison
between
the
FDA,
the
IRB,
Investigators,
and
the
new
researchers
in
Africa
with
whom
I
work.
They
have
a
totally
positive
attitude— Research
Staff.
Additionally,
we
can
offer
consultation
and
guidance
regarding
and
are
efficient,
effective,
responsive,
and
the
application
to
the
FDA
regarding
your
product
or
device,
support
for
FDA
flexible.”
and
IRB
submissions,
assistance
with
registering
trials
on
ClinicalTrials.gov,
assistance
with
Pre-­‐IND
meetings,
Type
B
Meetings
and
other
regulated
~Dr.
Judi
Chamberlin
U.S.
Military
HIV
Research
Program
meeting
requests,
and
guidance
for
FDA
audits.
Kisumu,
Kenya
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[6]

7.
Scientific
Administrative
Support
Often
it
is
necessary
to
provide
scientific
administrative
support
for
a
project
that
may
not
have
a
dedicated
individual
to
perform
these
services,
or
does
not
have
a
sufficient
amount
of
this
work
to
employ
a
full-­‐time
staff
member
to
handle.
This
often
results
in
these
services
being
assigned
to
members
of
the
team
with
other
duties.
With
competing
projects,
timelines,
and
efficiency
in
mind,
EmpiriStat
recognizes
these
challenges
and
provides
the
following
services
to
support
your
team:
Administrative
management
of
Data
and
Safety
For personalized attention Monitoring
Boards,
preparation
and
distribution
of
paper
and
electronic
contact us at: documents,
on-­‐site
management
of
local
or
international
conferences,
and
coordination
of
Investigator
kick-­‐off
meetings.
Also
provided
are
the
coordination
and
scheduling
of
science
team
meetings,
and
taking
minutes
EmpiriStat, Inc.
during
these
group
collaborations.
13694 Sam Hill Drive
Mount Airy, MD 21771
Tel: 866.935.STAT Biostatistical
Synergy
Fax: 866-.276.STAT derived
from
the
Greek
synergos,
συνεργός
meaning
working
together
Email: info@empiristat.com
Synergy
is
when
two
or
more
different
entities
cooperate
advantageously
for
a
final
outcome.
We
think
with
EmpiriStat’s
teamwork,
we
will
help
you
produce
an
overall
better
result
than
if
you
were
working
toward
the
same
goal
individually.
We
take
pride
in
our
ability
to
provide
the
highest
quality
services
with
an
appropriately
staffed
team
while
maintaining
our
responsiveness
and
flexibility
of
a
smaller
company.
It’s
a
promised
standard
from
us
that
includes
expertise,
mentoring,
and
support
from
a
team
of
experts
who
understand
your
needs.
Our
goal
is
always
to
help
you
succeed
by
www.empiristat.com working
as
a
part
of
your
team.
We
will
tailor
a
project
plan
to
meet
the
needs
of
every
project,
whether
you
need
full
scope
global
services
or
only
one
particular
service,
such
as
statistical
analysis
and
programming.
It
is
our
absolute
goal
to
help
you
succeed
by
fully
integrating
and
working
as
part
of
your
team.
“I’d
heard
Empiristat
would
be
a
good
company
to
handle
our
statistical
analysis.
They
were
very
patient
while
we
waited
for
regulatory
clearance,
then
incredibly
fast
and
efficient
when
clearance
finally
came.
Their
data
cleaning
was
nothing
short
of
amazing,
and
when
I
asked
them
on
short
notice
to
write
some
abstracts
for
conferences,
I
was
blown
away
by
how
quickly
this
was
done—and
they
were
extremely
well-­‐written.
I
can’t
say
anything
bad
about
Empiristat.”
~Mark
Breda
Makerere
University
School
of
Medicine
Kampala,
Uganda
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[7]

8. EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
[8]